Private Label Father John's Medicine Plus

Private Label Father John's Medicine Plus
SPL v1
SPL
SPL Set ID a7b05fbb-200e-2433-e053-2995a90a5275
Route
ORAL
Published
Effective Date 2019-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Phenylephrine (4 mg) Chlorpheniramine
Inactive Ingredients
Saccharin Sucrose Glycerin Anhydrous Citric Acid Fd&c Red No. 40 Fd&c Blue No. 1 Sodium Chloride Water Sodium Citrate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-06-17

Description

Each 30 mL (2 tablespoonfuls) contain: Dextromethorphan HBr, 10mg Phenylephrine HCl, 10mg Chlorpheniramine Maleate, 4mg


Medication Information

Warnings and Precautions

WARNINGS: Do not excees recommended dosage

Indications and Usage

For temporarily relief of couch and allergy symptoms, including coughing, nasal congestion, and runny nose.

Dosage and Administration

DO NOT take more than 12 tablespoonfuls in 24 hours

Adults and Children 12 years and older: take 2 tablespoons every 4 hours

Children under 12 years old: ask a doctor

Description

Each 30 mL (2 tablespoonfuls) contain: Dextromethorphan HBr, 10mg Phenylephrine HCl, 10mg Chlorpheniramine Maleate, 4mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

Citric acid

FD&C Red #40

FD&C Blue #1

Glycerin

Purified water

Sodium benzoate

Sodium chloride

Sodium citrate

Sodium saccharin

Sucrose

Section 51945-4

'

Section 55105-1

Cough Supressant

Nasal Decongestant

Anthihistamine

Section 55106-9

Each 30 mL (2 tablespoonfuls) contain:

Dextromethorphan HBr, 10mg

Phenylephrine HCl, 10mg

Chlorpheniramine Maleate, 4mg


Structured Label Content

Indications and Usage (34067-9)

For temporarily relief of couch and allergy symptoms, including coughing, nasal congestion, and runny nose.

Dosage and Administration (34068-7)

DO NOT take more than 12 tablespoonfuls in 24 hours

Adults and Children 12 years and older: take 2 tablespoons every 4 hours

Children under 12 years old: ask a doctor

Warnings and Precautions (34071-1)

WARNINGS: Do not excees recommended dosage

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Citric acid

FD&C Red #40

FD&C Blue #1

Glycerin

Purified water

Sodium benzoate

Sodium chloride

Sodium citrate

Sodium saccharin

Sucrose

Section 51945-4 (51945-4)

'

Section 55105-1 (55105-1)

Cough Supressant

Nasal Decongestant

Anthihistamine

Section 55106-9 (55106-9)

Each 30 mL (2 tablespoonfuls) contain:

Dextromethorphan HBr, 10mg

Phenylephrine HCl, 10mg

Chlorpheniramine Maleate, 4mg


Advanced Ingredient Data


Raw Label Data

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